Repeat Surgery for Patients With Post-operative Trachomatous Trichiasis Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 886
- 试验地点
- 2
- 主要终点
- Number of Eyelids With Post-operative Trichiasis Within 12 Months
研究概览
简要总结
The objective of this study is to determine if there is a significant difference in post-operative trichiasis at 12 months comparing a new procedure, the Bevel/rotate/advance procedure (BRAP), to the Trabut procedure among repeat surgery patients.
详细描述
The investigators will randomize participants with previously operated trichiasis on a 1:1 basis to receive either the Bevel/rotate/advance procedure (BRAP) or the Trabut procedure. The participants will be followed at 1 day, 2 weeks, 3-6 months, and then 12 months following the surgery. The primary study endpoint is recurrence of post-operative trichiasis within 12 months of surgery. The investigators will conduct logistic regression analysis comparing post-operative trichiasis recurrent rates in participants receiving BRAP versus participants receiving Trabut. Adjusted analyses will account for demographic characteristics as well as trichiasis severity prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older
- •At least one eyelid with post-operative upper eyelid trichiasis
- •Willing to comply with all study procedures and be available for the duration of the study
排除标准
- •Inability to provide independent, informed consent
研究组 & 干预措施
BRAP (Bevel/rotate/advance procedure)
The BRAP procedure is a full-thickness beveled full-thickness incision
干预措施: BRAP (Bevel/rotate/advance procedure) (Procedure)
Trabut 3 mm
The Trabut procedure is a partial-thickness incision through the tarsal conjunctiva and tarsus parallel to the eyelid margin and 3 mm above the lash line.
干预措施: Trabut (Procedure)
结局指标
主要结局
Number of Eyelids With Post-operative Trichiasis Within 12 Months
时间窗: 10-20 months
Presence of post-operative trichiasis defined as at least one trichiatic eyelashes or evidence of recent epilation. Trichiatic eyelashes are eyelashes touching the globe with the eye in the primary gaze. The outcome will be assessed at 3-6 months and at 12 months. If the eyelid has trichiasis at 2 weeks, but not at 3-6 months or 12 months, the eyelid will not be considered to have post-operative trichiasis. Due to COVID, the visit window for the Month 12 visits ranged from 10-20 months.
次要结局
- Number of Eyelids With Presence of Post-operative Trichiasis Within 3-6 Months(3-6 months)
- Number of Eyelids With Each of the Trichiasis Severity Levels at 3-6 Months(3-6 months)
- Change in Severity of Post-operative Trichiasis Between 3-6 Months and 1 Year Using Grading System(10-20 months)
- Cumulative Number of Eyelids With Presence of Pyogenic Granulomas Within 10-20 Months(10-20 months)
- Number of Eyelids With Each of the Trichiasis Severity Levels at 12 Months(10-20 months)
- Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 3-6 Months(3-6 months)
- Number of Eyelids With Moderate/Severe Eyelid Contour Abnormalities at 12 Months(10-20 months)